# K092810: EP-Workmate System, Version 4.2

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Oct 9, 2009 after 28 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000248 (2000). 11 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063277: Mapmate, Ep Medsystems, Inc. (2006) Summary page 1.

## Most influential descendants
- K132073: EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module (2013), 31 descendants of its own
- K151911: WorkMate Claris System, WorkMate Claris System Display Plus (2015), 30 descendants of its own
- K160218: AutoMark Module (2016), 28 descendants of its own
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (2018), 27 descendants of its own
- K182644: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 26 descendants of its own

## Indications for use
The EP-WorkMate TM System is indicated for use during clinical electrophysiology procedures.

Source page: https://510kreport.com/device/K092810
Methodology: https://510kreport.com/methodology